Back to resultsLymph Node Ratio and Kras Mutation in R Colon Cancer
Primary Purpose
Colon Cancer Stage III
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
k ras
Panitumumab
Sponsored by
About this trial
This is an interventional basic science trial for Colon Cancer Stage III
Eligibility Criteria
Inclusion Criteria:
- Stage III colon cancer
Exclusion Criteria:
- Stage I, II, IV
Sites / Locations
- Mansoura University Oncology Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients
Arm Description
LNR measured by (number of metastatic lymph nodes/total number of lymph nodes excised). and K ras (polymerase chain reaction (PCR) and pyrosequencing targeted for KRAS codons 12-13 was performed )
Outcomes
Primary Outcome Measures
LNR and K ras were evaluated with correlated with different clinicopathological parameters (Gender, CEA, tumor size, tumor grade and response to treatment).
impact on response
Secondary Outcome Measures
LNR and K ras were evaluated and ASSOCIATION with PFS and OS.
impact on survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04342676
Brief Title
Lymph Node Ratio and Kras Mutation in R Colon Cancer
Official Title
Lymph Node Ratio and Kras Mutation in Risk Stratification of Colon Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
August 25, 2019 (Actual)
Study Completion Date
August 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
clinical impact of LN ratio with Kras expression in colon cancer
Detailed Description
LNR and K ras were evaluated with correlated with different clinicopathological parameters of the patients, PFS and OS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer Stage III
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
433 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients
Arm Type
Experimental
Arm Description
LNR measured by (number of metastatic lymph nodes/total number of lymph nodes excised). and K ras (polymerase chain reaction (PCR) and pyrosequencing targeted for KRAS codons 12-13 was performed )
Intervention Type
Device
Intervention Name(s)
k ras
Intervention Description
K ras
Intervention Type
Drug
Intervention Name(s)
Panitumumab
Other Intervention Name(s)
vectibex
Intervention Description
vectibex in stage iv
Primary Outcome Measure Information:
Title
LNR and K ras were evaluated with correlated with different clinicopathological parameters (Gender, CEA, tumor size, tumor grade and response to treatment).
Description
impact on response
Time Frame
2 years
Secondary Outcome Measure Information:
Title
LNR and K ras were evaluated and ASSOCIATION with PFS and OS.
Description
impact on survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage III colon cancer
Exclusion Criteria:
Stage I, II, IV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tawfik A Elkhodary, MD
Organizational Affiliation
Oncology Center Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University Oncology Center
City
Mansoura
State/Province
Ad Daqahliyah
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
after publication
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Lymph Node Ratio and Kras Mutation in R Colon Cancer
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